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The Effect of NAC in Decreasing the Incidence of Linezolid-induced Thrombocytopenia in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05944458
Recruitment Status : Recruiting
First Posted : July 13, 2023
Last Update Posted : January 17, 2024
Sponsor:
Information provided by (Responsible Party):
Mohamed Abdeltawab, Helwan University

Study Description
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Brief Summary:
  • Study the effect of acetylcysteine on decreasing the incidence of LIT in critically ill patients.
  • Study the impact of acetylcysteine on the time to onset of LIT and the time to recovery of platelets.

Condition or disease Intervention/treatment Phase
Linezolid Induced Thrombocytopenia Drug: N acetyl cysteine Phase 4

Detailed Description:

Primary outcome: difference in incidence of LIT between patients who received NAC and patients who didn't.

  • Primary outcome definition: Defined as platelets < 150000 OR decrease > 50% of baseline platelets.
  • Secondary outcome: difference in Time to onset of LIT and time to recovery between the 2 groups.
  • Secondary outcome definitions: after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts > 70% of baseline values.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of N-acetylcysteine in Decreasing the Incidence of Linezolid-induced Thrombocytopenia in Critically Ill Patients
Actual Study Start Date : August 1, 2023
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Acetylcysteine group

Generic name: N-acetylcysteine.

  • Trade name: Fluimucil.
  • Company: Zambon.
  • Dosage form: ampoules for intravenous administration.
  • Dose: 600mg taken every 12 hours daily with a fixed dose as there is no need for renal or hepatic adjustment, starting with the inception of linezolid therapy.
  • Duration: at least one day or more
 Drug: N acetyl cysteine
Fluimucil 600 mg iv to be taken twice daily as infusion
Other Names:
  • Fluimucil
  • NAC
Placebo Comparator: Placebo
They will receive placebo drug.
 Drug: N acetyl cysteine
Fluimucil 600 mg iv to be taken twice daily as infusion
Other Names:
  • Fluimucil
  • NAC


Outcome Measures
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Primary Outcome Measures :
  1. difference in incidence of LIT between patients who received NAC and patients who didn't. [ Time Frame: One year ]
    Defined as platelets < 150000 OR decrease > or = 50% of baseline platelets.


Secondary Outcome Measures :
  1. difference in Time to onset of LIT and time to recovery between the 2 groups [ Time Frame: One year ]
    after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts > 70% of baseline values


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients, age > or = 18 years old, admitted to the ICU with different indications.
  • Candidates for intravenous linezolid therapy for > or =1 day.

Exclusion Criteria:

  • Taking any myelosuppressive drug.
  • Baseline platelets < 50000.
  • Patients with hematological malignancy.
  • COVID-19 patients.
  • Patients with immune thrombocytopenia.
  • Patients who refused to sign the informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05944458


Contacts
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Contact: Abdelhameed I Ebid, Phd 00201001423032 Nouran100@yahoo.co.uk
Contact: Mahmoud I Mostafa, Phd 00201006605563 Mahmoud.ibrahim@pharm.helwan.edu.eg

Locations
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Egypt
15 May hospital Recruiting
Cairo, Egypt
Contact: Marwa Soliman    00201016994685    Drmarawsoliman@gmail.com   
Contact       Drmarawsoliman@gmail.com   
Sponsors and Collaborators
Helwan University
Investigators
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Principal Investigator: Abdelhameed I Ebid, Phd Faculty of pharmacy, Helwan university
More Information
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Responsible Party: Mohamed Abdeltawab, Clinical pharmacist, Helwan University
ClinicalTrials.gov Identifier: NCT05944458    
Other Study ID Numbers: 11041990
First Posted: July 13, 2023    Key Record Dates
Last Update Posted: January 17, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Cytopenia
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
 Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes